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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PERICARDIOCENTESIS KIT; CATHETER, IRRIGATION
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MERIT MEDICAL SYSTEMS, INC. PERICARDIOCENTESIS KIT; CATHETER, IRRIGATION Back to Search Results
Catalog Number PC101
Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Disinfection Or Sterilization Issue (2909)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2014
Event Type  malfunction  
Event Description
The distributor reported there is a small hole in the clear film material of the package causing a breach in the sterile barrier.This was identified during their initial inspection of received product.The device was not sent to a user facility.
 
Manufacturer Narrative
Device evaluation.The device has not been returned for evaluation.A follow up report will be submitted when the evaluation has been completed.
 
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Brand Name
PERICARDIOCENTESIS KIT
Type of Device
CATHETER, IRRIGATION
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
south jordan UT
Manufacturer Contact
jerry mcphie
1600 west merit pkwy.
south jordan, UT 84095
8012084491
MDR Report Key3829919
MDR Text Key4403931
Report Number1721504-2014-00054
Device Sequence Number1
Product Code GBX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 02/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2016
Device Catalogue NumberPC101
Device Lot NumberT536573
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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